The Diagnostic Performance of BMO-MRW and RNFL Thickness and Their Combinational Index Using Artificial Neural Network

Completed

• Conditions: Tomography, Optical Coherence; Glaucoma

• Registration Number: NCT03257020
• Lead Sponsor: Pusan National University Hospital

Brief Summary

This study evaluates the relationship between BMO-MRW and RNFL thickness measured by OCT. SD-OCT exam will be performed to all patients in this study.

Detailed Description

spectral domain optical coherence tomography, SD-OCT, (Heidelberg Engineering, Heidelberg, Germany) is a widely used commercial device in ophthalmology field. For a long time, retinal nerve fiber layer (RNFL) thickness was measured with OCT to detect and follow up glaucoma patients. Bruch's membrane opening - minimum rim width (BMO-MRW) is relatively new parameter which measures the minimum distance between Bruch's membrane opening to internal limiting membrane (ILM). BMO-MRW,a new parameter, is known to have better diagnostic performance than RNFL thickness and recently, many researches has been performed on this new parameter. SD-OCT can measure RNFL thickness and BMO-MRW at the same time. The test procedure is not different from RNFL thickness measurement but only software implemented in OCT device calculates BMO-MRW as well as RNFL thickness. The investigators are going to compare these two parameters and find out the relationship between two parameters.

Study Timeline

• Study Start: 2015-08-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-08
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-22
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

• Age > 18 years with a clear cornea and clear ocular media
• BCVA ≥ 20/40
• Refractive error within ± 6.0 diopters (D) of 0 and astigmatism ± 3.0 D of 0

Exclusion Criteria

• uveitis
• secondary glaucoma
• corneal abnormalities
• non-glaucomatous optic neuropathies
• previous trauma
• ocular surgery or laser treatment
• any other eye disease except glaucoma.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bruch's membrane opening - minimum rim width (BMO-MRW)	5~10 minutes	SD-OCT will be performed to the patients to measure BMO-MRW by trained glaucoma specialist.

Secondary Outcome Measures

Name	Time	Method
Retinal nerve fiber layer (RNFL) thickness	5~10 minutes	SD-OCT will be performed to the patients to measure RNFL thickness. This is measured at the same time as BMO-MRW, not separately.

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of